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Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

Primary Purpose

Lupus Nephritis

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Mycophenolate mofetil
Azathioprine
Prednisolone
Sponsored by
Genovate Biotechnology Co., Ltd.,
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lupus Nephritis focused on measuring Systemic Lupus Erythematosus, Lupus Nephritis, Mycophenolate Mofetil, Azathioprine, Maintenance Therapy, Prednisolone, Serum albumin, Serum creatinine, Spot urine protein/creatinine ratio

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of lupus nephritis.
  • Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization.
  • Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization.

Exclusion Criteria:

  • Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis.
  • Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids.
  • Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks.
  • Previous kidney transplant or planned transplant.
  • Presence of life threatening complications such as cerebral lupus or severe infection.
  • Presence of liver dysfunction.
  • Presence of COPD or asthma requiring oral steroids.
  • Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus.
  • Presence of persistent hematuria or pyuria for causes other than lupus nephritis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    MMF 500mg

    MMF 750mg

    AZA

    Arm Description

    Mycophenolate mofetil 500mg, PO BID

    Mycophenolate mofetil 750mg, PO BID

    Azathioprine 1mg/kg, PO BID

    Outcomes

    Primary Outcome Measures

    Change in serum albumin
    Change in serum creatinine
    Change in spot urine protein/creatinine ratio

    Secondary Outcome Measures

    Change in serum albumin
    Change in serum creatinine
    Change in spot urine protein/creatinine ratio
    Change in cholesterol
    Change in triglyceride
    Change in complete blood count/differential count (CBC/DC)
    Change in number of subjects with doubling of serum creatinine
    Change in the average daily dose of oral prednisolone

    Full Information

    First Posted
    October 25, 2016
    Last Updated
    March 1, 2017
    Sponsor
    Genovate Biotechnology Co., Ltd.,
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02949349
    Brief Title
    Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
    Official Title
    Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2015 (undefined)
    Primary Completion Date
    December 30, 2016 (Actual)
    Study Completion Date
    January 25, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Genovate Biotechnology Co., Ltd.,

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study is designed to compare the safety and efficacy of Mycocep Capsules (Mycophenolate Mofetil) and a marketed Azathioprine formulation, Imuran Azathioprine Tablets, in the maintenance therapy of lupus nephritis.
    Detailed Description
    This study is designed to compare the two different doses of Mycocep Capsules (1.0g/day & 1.5g/day) and Imuran Azathioprine Tablets (2mg/kg/day), all in combination with low-dose prednisolone (≤10mg/day) as maintenance treatment for lupus nephritis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lupus Nephritis
    Keywords
    Systemic Lupus Erythematosus, Lupus Nephritis, Mycophenolate Mofetil, Azathioprine, Maintenance Therapy, Prednisolone, Serum albumin, Serum creatinine, Spot urine protein/creatinine ratio

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    MMF 500mg
    Arm Type
    Experimental
    Arm Description
    Mycophenolate mofetil 500mg, PO BID
    Arm Title
    MMF 750mg
    Arm Type
    Experimental
    Arm Description
    Mycophenolate mofetil 750mg, PO BID
    Arm Title
    AZA
    Arm Type
    Active Comparator
    Arm Description
    Azathioprine 1mg/kg, PO BID
    Intervention Type
    Drug
    Intervention Name(s)
    Mycophenolate mofetil
    Other Intervention Name(s)
    Mycocep Capsules
    Intervention Description
    Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Azathioprine
    Other Intervention Name(s)
    Imuran Azathioprine Tablets
    Intervention Description
    Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
    Intervention Type
    Drug
    Intervention Name(s)
    Prednisolone
    Intervention Description
    Daily dose not more than 10mg, orally, for 24 weeks.
    Primary Outcome Measure Information:
    Title
    Change in serum albumin
    Time Frame
    24 weeks treatment
    Title
    Change in serum creatinine
    Time Frame
    24 weeks treatment
    Title
    Change in spot urine protein/creatinine ratio
    Time Frame
    24 weeks treatment
    Secondary Outcome Measure Information:
    Title
    Change in serum albumin
    Time Frame
    12 weeks treatment
    Title
    Change in serum creatinine
    Time Frame
    12 weeks treatment
    Title
    Change in spot urine protein/creatinine ratio
    Time Frame
    12 weeks treatment
    Title
    Change in cholesterol
    Time Frame
    24 weeks treatment
    Title
    Change in triglyceride
    Time Frame
    24 weeks treatment
    Title
    Change in complete blood count/differential count (CBC/DC)
    Time Frame
    24 weeks treatment
    Title
    Change in number of subjects with doubling of serum creatinine
    Time Frame
    24 weeks treatment
    Title
    Change in the average daily dose of oral prednisolone
    Time Frame
    24 weeks treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Diagnosis of lupus nephritis. Currently receiving maintenance therapy with Azathioprine, Mycophenolate Mofetil, Mycophenolate Sodium, or Cyclosporine for lupus nephritis for at least 3 months prior to randomization. Stable use of low dose (≤10mg/day) oral prednisolone for lupus nephritis for at least 3 months prior to randomization. Exclusion Criteria: Untreated, not in need of immunosuppressive treatment (in addition to corticosteroids), currently receiving induction therapy, or not responding to Azathioprine, Mycophenolate Mofetil or Mycophenolate Sodium as induction or maintenance therapy for lupus nephritis. Currently receiving or anticipated to receive cyclophosphamide or IV pulse of corticosteroids. Currently receiving continuous dialysis starting more than 2 weeks before randomization, and/or with an anticipated duration of more than 8 weeks. Previous kidney transplant or planned transplant. Presence of life threatening complications such as cerebral lupus or severe infection. Presence of liver dysfunction. Presence of COPD or asthma requiring oral steroids. Presence of bone marrow insufficiency or pure red cell aplasia unrelated to active systemic lupus erythematosus. Presence of persistent hematuria or pyuria for causes other than lupus nephritis.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ming-Han Chen, M.D., Ph.D.
    Organizational Affiliation
    Taipei Veterans General Hospital, Taiwan, R.O.C.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Mycophenolate Mofetil Versus Azathioprine for Maintenance Therapy of Lupus Nephritis

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